January 18, 2012 -- Minneapolis -- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
announced today that an interim analysis of the FAME II trial has found
a highly statistically significant reduction in the need for hospital
readmission and urgent revascularization when Fractional Flow Reserve
(FFR)-guided assessment was used to direct treatment in patients with
coronary artery disease. As a result of the positive interim analysis,
the FAME II independent Data Safety Monitoring Board (DSMB) has
recommended investigators stop patient enrollment in this trial as the
DSMB considers it unethical to continue to randomize patients to optimal
medical therapy (OMT) alone.

FFR is a physiological index used to determine the hemodynamic severity
of narrowings in the coronary arteries, and is measured using St. Jude
Medical's PressureWire(TM) Aeris and PressureWire(TM) Certus. FFR specifically
identifies which coronary narrowings are responsible for obstructing the
flow of blood to a patient's heart muscle (called ischemia), and guides
the interventional cardiologist in determining which lesions warrant
stenting, resulting in improved patient outcomes and reduced healthcare
costs.

The DSMB recommended that St. Jude Medical stop patient enrollment in
its FAME II trial due to increased patient risk of major adverse cardiac
events (MACE) among patients randomized to OMT alone compared to
patients randomized to OMT plus FFR-guided PCI. In particular, patients
receiving OMT alone experienced a highly statistically significant
increased risk of hospital readmission and urgent revascularization, and
the DSMB determined that this difference was highly unlikely to change
with inclusion of more patients. The data currently reflect no observed
difference in the rates of death or heart attack.

The FAME II trial may provide new insights about the benefits of
coronary intervention and answer questions raised by the COURAGE (Clinical
Outcomes Utilizing
Revascularization and Aggressive
Drug Evaluation) trial, which demonstrated
no difference in the outcomes between PCI plus OMT compared to OMT
alone. However, the COURAGE study did not require use of PressureWire(TM)
FFR measurement technology.

"The FAME II trial is unprecedented in its ability to provide further
answers and evidence regarding the optimal way to treat patients with
coronary artery disease and myocardial ischemia," said Bernard De
Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and
coordinating clinical investigator of the FAME II trial. "What we
observed to date regarding urgent revascularizations validates the
profound role that FFR-guided therapy has in improving patient outcomes.
This is further evidence that FFR should be considered the standard of
care for patients with coronary artery disease."

The FAME II trial will continue following patients currently enrolled
according to the trial protocol and will not enroll any new patients.
The trial randomized 1,219 patients with stable coronary artery disease
in 28 centers in Europe, the U.S. and Canada.

"The original FAME trial demonstrated that FFR guidance improves
outcomes in patients with stable coronary artery disease and two or
three vessel disease. Today, FAME II confirms that PCI is beneficial for
patients with one, two and three vessel disease whose ischemia has been
documented by FFR," said Frank Callaghan, president of the St. Jude
Medical Cardiovascular Division. "Due to the statistically and
clinically compelling differences in the number of patients returning to
the hospital for an urgent revascularization procedure - which can be
considered a surrogate for a repeat heart attack or death - we support
the recommendation of the DSMB and the trial's Steering Committee. We
expect the data will continue to reveal the important role that FFR
plays in developing an optimal treatment strategy."

Data will be published as information is analyzed, with initial results
expected to be presented in 2012.

About the Original FAME TrialThe original FAME (Fractional Flow Reserve (FFR) vs. Angiography in
Multivessel Evaluation) trial was a randomized, prospective,
multi-center trial which enrolled 1,005 patients with multivessel
coronary artery disease. The FAME study compared outcomes for patients
whose treatment was guided by FFR to those whose treatment was guided
only by angiography using St. Jude Medical's PressureWire Certus
technology. The 12-month results, published in the Jan. 15, 2009 issue
of the New England Journal of Medicine, demonstrated that
instances MACE were reduced by 28 percent for patients whose treatment
was guided by FFR rather than by standard angiography alone. Two-year
results demonstrated that patients who received FFR-guided treatment
continued to experience improved outcomes over time, including a 34
percent reduction in risk of death or heart attack.

About St. Jude MedicalSt. Jude Medical develops medical technology and services that focus on
putting more control into the hands of those who treat cardiac,
neurological and chronic pain patients worldwide. The company is
dedicated to advancing the practice of medicine by reducing risk
wherever possible and contributing to successful outcomes for every
patient. St. Jude Medical is headquartered in St. Paul, Minn. and has
four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com.

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The statements made by the Company are based upon management's current
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could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company's control and the
risk factors and other cautionary statements described in the Company's
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company's Annual Report on Form
10-K for the fiscal year ended January 1, 2011 and Quarterly Report on
Form 10-Q for the fiscal quarter ended October 1, 2011. The Company does
not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.